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Autism Spectrum DisorderNCT05644366

Postural Control Instability in Children With Mild Autism

A study of Autism Spectrum Disorder, run by Texas Woman's University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: Individuals diagnosed with Autism Spectrum Disorder (ASD) exhibit some type of motor control impairment, for instance, motor apraxia and history of gross motor delay that could lead to increased risk of fall. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Autism Spectrum Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
14 Aug 2014to 14 Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children from 7-12 years of age, male or female
  • mild ASD diagnosis (as determined by a medical doctor)
  • capable of ambulating independently.

Who cannot join

  • children with additional neurological problems
  • children with visual problems
  • children unable to tolerate walking or standing barefoot
  • children who have fallen three or more times in the last three months
  • children with vestibular problems.

About this study

Official title: Proprioception and Vestibular Alterations Affect Postural Control in Children With Mild Autism: A Pilot Study

Objective: Individuals diagnosed with Autism Spectrum Disorder (ASD) exhibit some type of motor control impairment, for instance, motor apraxia and history of gross motor delay that could lead to increased risk of fall. This pilot research was designed to assess and characterize static postural stability and create a starting point to better understand and describe postural control in children with mild autism. Method: We measured static postural control with center of pressure (COP) displacement in 10 children with mild autism during eight sensory conditions that challenge and cancel the visual, proprioceptive and vestibular systems.

Read the detailed description

Materials and methods Institutional Review Board (IRB) approval at the University of Puerto Rico, Medical Science Campus has obtained prior the recruitment of the participants. Parents of children diagnosed with mild ASD who were interested in the study called the number on the recruitment flyer. The PI spoke with the parent to assess whether their child qualified for the study based on the following inclusion and exclusion criteria.

Balance Assessment Protocol

The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions. The first four conditions were executed over a stable surface and consisted of the following: (1) eyes open (EO) -evaluates visual, vestibular and proprioceptive systems, (2) eyes closed (EC) -eliminates visual input, evaluates vestibular and proprioceptive system, (3) eyes open while moving head up and down (at 60 beats per minute) (EO HUD) -evaluates visual and proprioceptive system and alters vestibular input, (4) eyes closed while moving the head up and down (EC HUD) -evaluates the effect of removing visual information, and the vestibular input being altered. The subjects then performed the same four tasks, this time standing on an unstable platform (high quality closed cell foam 19 inches long x 15 inches width x 2.25 inches)with the purpose of altering the proprioceptive input and increasing dependence on the visual and vestibular systems.

Being tested
Postural Control Balance Assessment
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postural Control Balance AssessmentOther

    Postural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.

Study groups in NCT05644366
Study groupRoleWhat they receive
Balance Assessment Children with AutismExperimentalPostural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.
Receives: Other: Postural Control Balance Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural Stability

    Postural stability was operationally defined by the center of pressure displacement measured by the MatScan® pressure mat. These sensors detect the displacement as the body sways anterior, posterior or laterally (right or left).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start14 Aug 2014
  3. Primary completion14 Aug 2015
  4. Study completion14 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644366
Sponsor's protocol ID
A2540214
Status last verified
Dec 2022
First submitted
28 Feb 2018
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ming X, Brimacombe M, Wagner GC. Prevalence of motor impairment in autism spectrum disorders. Brain Dev. 2007 Oct;29(9):565-70. doi: 10.1016/j.braindev.2007.03.002. Epub 2007 Apr 30.

    PubMed 17467940

  • Teitelbaum P, Teitelbaum O, Nye J, Fryman J, Maurer RG. Movement analysis in infancy may be useful for early diagnosis of autism. Proc Natl Acad Sci U S A. 1998 Nov 10;95(23):13982-7. doi: 10.1073/pnas.95.23.13982.

    PubMed 9811912

  • Fournier KA, Kimberg CI, Radonovich KJ, Tillman MD, Chow JW, Lewis MH, Bodfish JW, Hass CJ. Decreased static and dynamic postural control in children with autism spectrum disorders. Gait Posture. 2010 May;32(1):6-9. doi: 10.1016/j.gaitpost.2010.02.007. Epub 2010 Apr 18.

    PubMed 20400311

  • Mari M, Castiello U, Marks D, Marraffa C, Prior M. The reach-to-grasp movement in children with autism spectrum disorder. Philos Trans R Soc Lond B Biol Sci. 2003 Feb 28;358(1430):393-403. doi: 10.1098/rstb.2002.1205.

    PubMed 12639336

  • Kohen-Raz R, Volkmar FR, Cohen DJ. Postural control in children with autism. J Autism Dev Disord. 1992 Sep;22(3):419-32. doi: 10.1007/BF01048244.

    PubMed 1383190

  • Fournier KA, Hass CJ, Naik SK, Lodha N, Cauraugh JH. Motor coordination in autism spectrum disorders: a synthesis and meta-analysis. J Autism Dev Disord. 2010 Oct;40(10):1227-40. doi: 10.1007/s10803-010-0981-3.

    PubMed 20195737

  • Blanche EI, Reinoso G, Chang MC, Bodison S. Proprioceptive processing difficulties among children with autism spectrum disorders and developmental disabilities. Am J Occup Ther. 2012 Sep-Oct;66(5):621-4. doi: 10.5014/ajot.2012.004234.

    PubMed 22917129

  • Shumway-Cook, A., & Woollacott, M. H. (2001a). Constraints of motor control. Motor control: Theory and practical applications (2nd ed., pp. 127-161). Philadelphia, Pa. ; London: Lippincott Williams & Wilkins.

  • Kern, J. K., Garver, C. R., Grannemann, B. D., Trivedi, M. H., Carmody, T., Andrews, A. A., & Mehta, J. A. (2007). Response to vestibular sensory events in autism. Research in Autism Spectrum Disorders, 1(1), 67-74. doi:10.1016/j.rasd.2006.07.006

  • Molloy CA, Dietrich KN, Bhattacharya A. Postural stability in children with autism spectrum disorder. J Autism Dev Disord. 2003 Dec;33(6):643-52. doi: 10.1023/b:jadd.0000006001.00667.4c.

    PubMed 14714933

  • Shumway-Cook, A., & Woollacott, M. H. (2001b). Development of postural control. Motor control: Theory and practical applications (2nd ed., pp. 192-221). Philadelphia, Pa. ; London: Lippincott Williams & Wilkins.

  • FUKUDA T. The stepping test: two phases of the labyrinthine reflex. Acta Otolaryngol. 1959 Mar-Apr;50(2):95-108. doi: 10.3109/00016485909129172. No abstract available.

    PubMed 13636842

  • Zammit GV, Menz HB, Munteanu SE. Reliability of the TekScan MatScan(R) system for the measurement of plantar forces and pressures during barefoot level walking in healthy adults. J Foot Ankle Res. 2010 Jun 18;3:11. doi: 10.1186/1757-1146-3-11.

    PubMed 20565812

  • Hansson EE, Beckman A, Hakansson A. Effect of vision, proprioception, and the position of the vestibular organ on postural sway. Acta Otolaryngol. 2010 Dec;130(12):1358-63. doi: 10.3109/00016489.2010.498024. Epub 2010 Jul 16.

    PubMed 20632903

  • O'sullivan, S. B. (2007). Examination of motor function: Motor control and motor learning. Physical rehabilitation (pp. 233-234) FA Davis Company Philadelphia.

Questions about this trial

What is this clinical trial studying?

A study of Autism Spectrum Disorder, run by Texas Woman's University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Stability (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644366, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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Clinical Trial NCT05644366 | AzTrials